Anodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery

NCT ID: NCT01601392

Last Updated: 2012-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study will to compare the long-term effect of anodal versus cathodal transcranial direct current stimulation (tDCS) on motor recovery in subacute stroke patients. Forty patients with subacute ischemic stroke will randomly assigned to one of three groups: Anodal, Cathodal and Sham. Each group will receive tDCS at an intensity of 2mA for 25 minutes daily for 6 consecutive days over the affected (Anodal, Sham) or unaffected (Cathodal) motor cortex. Patients will be assessed with National Institutes of Health Stroke Scale (NIHSS), the Barthel index (BI) and the Medical Research Council (MRC) muscle strength scale at baseline, after end of the 6th tDCS session, and then 1, 2 and 3 months later. Motor cortical excitability will be measured at baseline and after the 6th session in both hemispheres.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anodal tDCS

Group Type EXPERIMENTAL

transcranial direct current stimulation (Anodal)

Intervention Type PROCEDURE

The anodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the affected hemisphere.

Cathodal tDCS

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation (Cathodal)

Intervention Type PROCEDURE

The Cathodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the unaffected hemisphere.

Sham

Group Type SHAM_COMPARATOR

transcranial direct current stimulation (Sham)

Intervention Type PROCEDURE

The sham group will receive sham tDCS for 25 minutes daily for 6 consecutive days on the affected hemisphere.

Interventions

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transcranial direct current stimulation (Anodal)

The anodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the affected hemisphere.

Intervention Type PROCEDURE

transcranial direct current stimulation (Cathodal)

The Cathodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the unaffected hemisphere.

Intervention Type PROCEDURE

transcranial direct current stimulation (Sham)

The sham group will receive sham tDCS for 25 minutes daily for 6 consecutive days on the affected hemisphere.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* acute hemiparesis with single thromboembolic non-hemorrhagic infarction documented by magnetic resonance imaging (MRI)
* Accept to participate in the study

Exclusion Criteria

* extensive infarction (taking all territories of middle cerebral artery)
* severe flaccid hemiplegia
* head injury
* Any other neurological disease other than stroke
* previous administration of tranquilizer
* patients who are unable to give informed consent because of severe aphasia, or cognitive deficit.
* Patients with no motor evoked response recorded from First Dorsal Interosseus (FDI) muscle of the affected hand
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dina Hatem Elhammady

OTHER

Sponsor Role lead

Responsible Party

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Dina Hatem Elhammady

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Eman M Khedr, Professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Faculty of Medicine, Assiut University

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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tDCS in stroke recovery

Identifier Type: -

Identifier Source: org_study_id

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